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NCT03374995 · ClinicalTrials.gov registry record · NA

Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer

A NA study of Breast Carcinoma and Radiation-Induced Dermatitis, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
NA
Development phase
25
Enrollment target
1
Study location

NCT03374995: Completed NA study of Breast Carcinoma and Radiation-Induced Dermatitis, sponsored by Wake Forest University Health Sciences.

NCT03374995 is a NA study of Breast Carcinoma and Radiation-Induced Dermatitis that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 25 participants, below the 770-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03374995, a NA study of Breast Carcinoma and Radiation-Induced Dermatitis, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
NA
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

This randomized pilot clinical trial studies how well topical keratin works in treating radiation dermatitis in patients with breast cancer. Radiation dermatitis is a skin condition that is a common side effect of radiation therapy. The affected skin becomes painful, red, itchy, and blistered. Topical keratin may help to improve skin appearance and hydration in patients with breast cancer.

Primary Outcome

The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. Participants will report in a total of 7 visits any experience with Grade I (faint or dull erythema; dry desquamation or Grade II (tender or bright erythema, patchy, moist desquamation) acute radiation dermatitis using the RTOG (Radiation Therapy Oncology Group) grading system with Grade II considered the worse outcome. Comparative effectiveness will include the numbe

Interventions

  • OTHER Quality-of-Life Assessment
  • OTHER Best Practice
  • DEVICE Topical Keratin

Study Locations (1)

North Carolina

  • Comprehensive Cancer Center of Wake Forest University - Winston-Salem

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2018-03-26
Est. Completion 2018-11-01
Phase NA
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT03374995 record still lists

NCT03374995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 770-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (97% lower).

The record links to 2 conditions, with Breast Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.

NCT03374995 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT03374995 about?

NCT03374995 is a clinical study titled "Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer". This randomized pilot clinical trial studies how well topical keratin works in treating radiation dermatitis in patients with breast cancer. Radiation dermatitis is a skin condition that is a common side effect of radiation therapy. The affected skin becomes painful, red, itchy, and blistered. Topic...

What is the current status of trial NCT03374995?

This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2018-03-26. Estimated completion is 2018-11-01.

What conditions does trial NCT03374995 study?

This clinical trial studies the following conditions: Breast Carcinoma, Radiation-Induced Dermatitis.

What interventions are being tested in trial NCT03374995?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Best Practice (OTHER), Topical Keratin (DEVICE).

Who is sponsoring clinical trial NCT03374995?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03374995 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03374995's enrollment target sits among peer trials

25 98th of 106 higher than 9 of 106 other Breast Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03374995, the US trial registry maintained by the National Library of Medicine. NCT03374995 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.